Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FDF 2024-10-04

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models

Applicant Actuated Medical, Inc.

K-Number K242325

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HAW 2024-10-04

Zeta Cranial Navigation System (ZNS131-US)

Applicant Zeta Surgical, Inc.

K-Number K242351

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GCJ 2024-10-04

TroCare TroKit Laparoscope Lens Wiper (CP000626)

Applicant TroCare, LLC

K-Number K241796

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FGB 2024-10-04

Video Ureteroscope System

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K241434

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ITI 2024-10-04

Power Wheelchair

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K-Number K241854

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POK 2024-10-04

EchoSolv AS

Applicant Echo IQ, Ltd.

K-Number K241245

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DYB 2024-10-04

AuST Steerable Sheath

Applicant CenterPoint Systems, LLC

K-Number K242106

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QDQ 2024-10-04

Lunit INSIGHT DBT v1.1

Applicant Lunit, Inc.

K-Number K242652

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HWC 2024-10-04

Treace Medical Concepts (TMC) Screw Fixation System

Applicant Treace Medical Concepts, Inc.

K-Number K242671

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QIH 2024-10-04

LVivo Software Application

Applicant Dia Imaging Analysis, Ltd.

K-Number K240553

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NGL 2024-10-04

BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K-Number K241869

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MAX 2024-10-04

IdentiTi II Interbody System

Applicant Alphatec Spine, Inc.

K-Number K242364

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